Cytosponge for Gastric Intestinal Metaplasia

Trial Title: Cytosponge for Gastric Intestinal Metaplasia

NCT ID: NCT05657080

Condition: Gastric Cancer
Gastric Intestinal Metaplasia
Gastric Atrophy

Conditions: Official terms:
Gastritis, Atrophic
Metaplasia

Conditions: Keywords:
early cancer detection
gastric premalignant lesions
non-invasive cancer screening

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Cytosponge-TFF3
Description: Cytosponge is a less invasive procedure than endoscopy and consists of an expandable, spherical mesh, which is attached to a string and contained within a soluble capsule. Five minutes after swallowing (once the capsule has dissolved), the spherical mesh, which measures around 3cm in diameter can be retrieved by pulling on the string. Upon retrieval the Cytosponge scrapes against the surface of the top of the stomach and oesophagus and collect epithelial cells. The Cytosponge sample is then placed into a preservative fluid and the specimen is processed for molecular tests. Trefoil Factor 3 (TFF3) is a protein that is expressed in intestinal type epithelia of the gastrointestinal tract. TFF3 is the best biomarker, which can be coupled to the Cytosponge to diagnose intestinal metaplasia.
Arm group label: Cases
Arm group label: Controls

Other name: Upper GI endoscopy

Other name: Blood sampling

Summary: Gastric cancer has a very poor prognosis. The disease is often diagnosed at a late stage, when curative treatment options are limited or ineffective. There is a condition that predisposes to gastric cancer, known in medical terms as Gastric intestinal metaplasia (GIM). This pre-cancerous condition can be diagnosed with an endoscopic camera test, but it often very subtle and can be missed at routine endoscopy. There is evidence that about 7% of gastric cancers are missed at previous endoscopy. The Cytosponge-trefoil factor 3 (TFF-3) is a pill on a string combined to a molecular biomarker which could help early diagnosis of gastric cancer and GIM. Cytosponge-TFF3 has been showed in previous research to be useful to diagnose Barrett's oesophagus, a condition of the food pipe similar to GIM. The aim of this study is to investigate the utility of the Cytosponge in combination with molecular biomakers to diagnose GIM

Detailed description: This is a case-control study whose goal is to compare the non-endoscopic test (Cytosponge-TFF3) to standard endoscopy to diagnose gastric intestinal metaplasia (GIM), a precursor lesion for gastric cancer. The main objective of the study is to determine the sensitivity and specificity of the Cytosponge-TFF3 to detect gastric intestinal metaplasia (GIM) affecting the proximal stomach. In parallel to this clinical study, a experimental study will be carried out aimed at evaluating the utility of molecular biomarkers to refine/improve the diagnostic accuracy of the Cytosponge test. The hypothesis is that the non-invasive Cytosponge, in combination with molecular biomarkers, can accurately detect GIM to the same extent as conventional, but more invasive, endoscopic procedures. Patients will be invited to participate in the study if they are due their surveillance endoscopy, because they have the disease of interest (GIM or GC; cases) or have been referred for an upper endoscopy for abdominal complaint (controls). On the day of the endoscopy the patient will swallow the Cytosponge under supervision of a trained research nurse prior to the endoscopic procedure. The participant will also provide information on demographics, clinical exposures (alcohol, tobacco, drugs), have measurements of weight and height taken and they will also complete a validated gastrointestinal symptoms questionnaire. A blood sample will be taken from the cannula used for the sedatives or through venepuncture. The patients will then undergo their planned endoscopy with additional sampling of gastric juice (suctioned through the endoscope) and some additional research biopsies in addition to a standardized clinical protocol to diagnose GIM. The above research procedures will be performed prior and during the endoscopy. No further research procedures will follow afterwards beyond the day of the endoscopy. The aim is to develop a non-invasive test which can be used to screen patients at risk for GIM to allow early detection and treatment of pre-cancerous gastric lesions and ultimately reduce the number of patients dying of gastric cancer.

Criteria for eligibility:

Study pop:
Cases and controls will be treated in the UK. Cases: - Patients with an existing diagnosis of proximal GIM referred for endoscopic surveillance will - Patients with newly diagnosed GIM who require a repeat endoscopy for complete endoscopy biopsy mapping. - Patients with a historical diagnosis of GIM retrieved from the pathology records and in need of endoscopic surveillance based on clinical guidelines. - Patients with gastric cancer (intestinal type) recruited from the multidisciplinary team meeting and undergoing endoscopy and laparoscopy as part of their regular cancer staging or surveillance. Controls will be referred from primary or secondary care with upper GI symptoms and no known premalignant conditions of the upper GI tract.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Any participant 18 years and above clinically fit for an endoscopy with GIM of the proximal stomach confirmed on previous biopsies or gastric adenocarcinoma of intestinal type (cases) - Any participant 18 years and above clinically fit for an endoscopy with upper GI symptoms leading to referral for endoscopy (controls) - Ability to provide informed consent Exclusion Criteria: - Individuals with a diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour (T2 staging and above), or symptoms of dysphagia. - Patients with previous diagnosis of Barrett's oesophagus oesophageal varices, stricture or requiring dilatation of the oesophagus. - Patients unable to stop anticoagulation therapy/medication timely before the procedure (heparin or tinzaparin, apixaban, rivaroxaban, dabigatran, edoxaban; 48 hours, warfarin; 5 days, clopidogrel; 7 days) - Individuals who have had a myocardial infarction or any cardiac event less than six months ago. - Individuals who have had a cerebrovascular event < 6 months ago where their swallowing has been affected - Patients who have had previous treatments such as Photodynamic therapy (PDT), Radiofrequency ablation or Argon Plasma Coagulation for dysplastic Barrett's oesophagus - Participants who are unable to provide informed consent. - Participants under age 18. NB - Endoscopy is generally avoided in pregnant women and therefore it is unlikely that any pregnant women will be included although pregnancy would not be an absolute contraindication. Pregnancy/ pregnancy test will not be recorded as part of the trial.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Cambridge Clinical Research Centre

Address:
City: Cambridge
Zip: CB20QQ
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Tara Evans

Phone: 01223763994
Email: tara.evans@nhs.net

Investigator:
Last name: Andreas Hadjinicolaou, MD
Email: Sub-Investigator

Start date: October 16, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: University of Cambridge
Agency class: Other

Collaborator:
Agency: University College London Hospitals
Agency class: Other

Collaborator:
Agency: Nottingham University Hospitals NHS Trust
Agency class: Other

Source: University of Cambridge

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05657080